Endothelial Function and IMT in Survivors of Hodgkin's Lymphoma

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dr. Dalit Modan, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00428688
First received: January 28, 2007
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

The aim of the proposed study is to assess endothelial function and IMT, as correlates of cardiovascular disease (CVD), in young adult Hodgkin's disease (HD) survivors, and to relate endothelial function to other risk factors including obesity, dyslipidemia, hyperinsulinemia and fasting glucose.


Condition
Hodgkin's Lymphoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Endothelial Function and IMT in Survivors Hodgkin's Lymphoma Patients

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Frequencey of endothelial dysfunction by FMD [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Disease free survival of Hodgkin's disease (HD) patients has improved dramatically over the past few decades. With the dramatic advance in patient's survival, the prevention and treatment of long-term adverse effects of chemotherapy and radiotherapy has become a major focus of interest. HD survivors have excess mortality compared with the age-matched general population, even after excluding disease relapse. A considerable proportion of the excess mortality is due to cardiovascular disease (CVD), principally ischemic heart disease and stroke.

The proposed study will assess endothelial function in HD survivors, using the non-invasive technique of brachial artery flow-mediated dilation (FMD), by high-resolution ultrasonography. We will also assess IMT. The results of these tests are independent predictors of atherosclerosis disease progression and cardiovascular event rates. This is a prospective study comprising 40 young-adult (aged 18-30 years) . The study will comprise 40 survivors of HD: 20 patients treated with chemotherapy and radiotherapy to the chest and 20 patients treated with chemotherapy alone. The patients will be compared to age and sex-matched patients from the data base of the endothelial function laboratory at the heart institute of the Sheba Medical Center. In addition to brachial artery endothelial function assessment, the patients will also undergo a physical examination including anthropometric measurements (height, weight, waist and hip circumference), and blood pressure. The evaluation will also include blood tests for glucose, lipid profile, CRP, AST, ALT and insulin. A medical history including smoking history and family history of CVD and dyslipidemia will be obtained.

Patients treated with radiotherapy to the chest will be compared to patients treated with chemotherapy alone and both patients will be compared to healthy controls. The patients will be characterized by age, risk factors for coronary heart disease and endothelial function as assessed by brachial artery FMD. We will establish the rate of endothelial function abnormalities in survivors of HD and its correlation with the other risk factors.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Young-adult survivors of Hodgkin's disease

Criteria

Inclusion Criteria:

  • Hodgkin's disease survivors over 18 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428688

Locations
Israel
The Endothelaial function lab, The Heart Institute, Sheba Medical Center, Israel
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Dalit Modan, M.D Sheba Medical Center
Principal Investigator: Michael Schechter, M.D Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Dalit Modan, Pediatirc Endocrinologist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00428688     History of Changes
Other Study ID Numbers: SHEBA-06-4359-DM-CTIL
Study First Received: January 28, 2007
Last Updated: December 12, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Hodgkin's lymphoma
cardiovascular disease
radiation therapy
Brachial artery flow-mediated dilation (FMD)

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014